NCT01672853

Simtuzumab (GS-6624) in the Prevention of Progression of Liver Fibrosis in Adults With Primary Sclerosing Cholangitis (PSC)

A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase Like 2 (LOXL2) in Subjects With Primary Sclerosing Cholangitis (PSC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 235 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate whether simtuzumab (GS-6624) is effective at preventing the progression of liver fibrosis in adults with primary sclerosing cholangitis (PSC).

Conditions

• Primary Sclerosing Cholangitis (PSC)

Interventions

Type	Name	Description
BIOLOGICAL	Simtuzumab	Subcutaneous injections weekly for a total of 96 injections
BIOLOGICAL	Placebo	Subcutaneous injections weekly for a total of 96 injections

Timeline

• Start date: 2013-03-04
• Primary completion: 2016-08-08
• Completion: 2016-08-24
• First posted: 2012-08-27
• Last updated: 2019-10-22
• Results posted: 2019-10-22

Locations

75 sites across 10 countries: United States, Belgium, Canada, Denmark, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study